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VICTOZA is a brand name for Liraglutide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , Geriatrics (>65 years of age). 7 WARNINGS AND PRECAUTIONS, Special Populations, Gastrointestinal disease; 4 DOSAGE AND ADMINISTRATION, Dosing considerations; 10 CLINICAL PHARMACOLOGY, Pharmacodynamics, Gastric emptying) Patients with mild, moderate and severe renal insufficiency (creatinine clearance 60-90 mL/min,…
Verbatim from this product's HC label. Tap a section to expand.
Dosage and Administration, Recommended Dose and Dosage Adjustment, Geriatrics). VICTOZA® (liraglutide injection) Product Monograph Page 5 of 71 2 Contraindications • Liraglutide is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
, Adverse Reaction Overview, Clinical Trial Adverse Drug Reactions, Gastrointestinal adverse events; and 4 DOSAGE AND ADMINISTRATIONDosage and Administration, Recommended Dose and Dosage Adjustment, Geriatrics). VICTOZA® (liraglutide injection) Product Monograph Page 5 of 71 2 Contraindications • Liraglutide is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • In patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• In pregnant or breastfeeding women. 1 Dosing Considerations For all patients VICTOZA® is administered once daily at any time, independent of meals. 6 mg once daily for at least one week. 6 mg dose is a starting dose intended to reduce gastrointestinal symptoms during initial titration.
2 mg once daily. 8 mg once daily to achieve maximum efficacy for glycemic control. VICTOZA® can be added to existing metformin therapy. The current dose of metformin can be continued unchanged at the discretion of the doctor. VICTOZA® can be added to combined metformin and sulfonylurea therapy.
During clinical trials doctors were advised, at their discretion, to lower the dose of sulfonylurea to minimize the risk of unacceptable hypoglycemia. Serious Warnings and Precautions Risk of Thyroid C-cell Tumours • Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C- cell tumours at clinically relevant exposures in both genders of rats and mice (See 16 NON-CLINICAL TOXICOLOGY).
It is unknown whether Victoza® causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. • Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
, Special Populations, Geriatrics;
, 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS and 16 NON-CLINICAL TOXICOLOGY) VICTOZA® (liraglutide injection) Product Monograph Page 6 of 71 VICTOZA® can be added to combined metformin and SGLT2i therapy. The current dose of metformin and the SGLT2i can be continued unchanged at the discretion of the doctor.
When using VICTOZA® with insulin, administer as separate injections. Never mix. It is acceptable to inject VICTOZA® and insulin in the same body region but the injections should not be adjacent to each other. In children and adolescents aged 10 years and above VICTOZA® can be added to existing metformin therapy with or without basal insulin.
The current dose of metformin can be continued unchanged at the discretion of the doctor. The current dose of basal insulin should be decreased at the discretion of the doctor. 2 Recommended Dose and Dosage Adjustment Renal Insufficiency: No dose adjustment is required for patients with mild, moderate or severe renal insufficiency (creatinine clearance 60-90 mL/min, 30-59 mL/min and < 30 mL/min respectively).
There is very limited or no clinical experience with VICTOZA® in patients with end- stage renal disease; use of VICTOZA® in these patients is not recommended (see 7 WARNINGS AND PRECAUTIONS, Special Populations; and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
73 m2) at baseline. No overall differences in safety or efficacy were seen in these patients compared to patients with normal renal function.
Hepatic Insufficiency:
There is limited clinical experience in patients with mild, moderate or severe hepatic insufficiency. No dose adjustment is required for patients with hepatic impairment. 8%) were 75 years of age and over. No overall difference in safety or efficacy were observed between these patients compared to younger patients, but greater sensitivity of older individuals cannot be ruled out.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Liraglutide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumours.
Patients should be counselled regarding the risk and symptoms of thyroid tumours. (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS and 16 NON-CLINICAL TOXICOLOGY) VICTOZA® (liraglutide injection) Product Monograph Page 6 of 71 VICTOZA® can be added to combined metformin and SGLT2i therapy.
The current dose of metformin and the SGLT2i can be continued unchanged at the discretion of the doctor. When using VICTOZA® with insulin, administer as separate injections. Never mix. It is acceptable to inject VICTOZA® and insulin in the same body region but the injections should not be adjacent to each other.
In children and adolescents aged 10 years and above VICTOZA® can be added to existing metformin therapy with or without basal insulin. The current dose of metformin can be continued unchanged at the discretion of the doctor. The current dose of basal insulin should be decreased at the discretion of the doctor.
2 Recommended Dose and Dosage Adjustment Renal Insufficiency: No dose adjustment is required for patients with mild, moderate or severe renal insufficiency (creatinine clearance 60-90 mL/min, 30-59 mL/min and < 30 mL/min respectively).
There is very limited or no clinical experience with VICTOZA® in patients with end- stage renal disease; use of VICTOZA® in these patients is not recommended (see 7 WARNINGS AND PRECAUTIONS, Special Populations; and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
73 m2) at baseline. No overall differences in safety or efficacy were seen in these patients compared to patients with normal renal function.
Hepatic Insufficiency:
There is limited clinical experience in patients with mild, moderate or severe hepatic insufficiency. No dose adjustment is required for patients with hepatic impairment. 8%) were 75 years of age and over. No overall difference in safety or efficacy were observed between these patients compared to younger patients, but greater sensitivity of older individuals cannot be ruled out.
4%) were 85 years of age or older at baseline. No overall difference in safety or efficacy was observed between these patients compared to younger patients (see 7 WARNINGS AND PRECAUTIONS, Special Populations; 8 ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions, Gastrointestinal adverse events; and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
6 mg once daily for at least one week. 6 mg dose is a starting dose intended to reduce gastrointestinal symptoms during initial titration. 6 mg per […]
4%) were 85 years of age or older at baseline. No overall difference in safety or efficacy was observed between these patients compared to younger patients (see 7 WARNINGS AND PRECAUTIONS, Special Populations; 8 ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions, Gastrointestinal adverse events; and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
6 mg once daily for at least one week. 6 mg dose is a starting dose intended to reduce gastrointestinal symptoms during initial titration. 2 mg once daily if additional glycemic control is required. 8 mg once daily if additional glycemic VICTOZA® (liraglutide injection) Product Monograph Page 7 of 71 control is required.
(See 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests) No data are available for children below 10 years of age. 4 Administration VICTOZA® is administered once daily at any time, independent of meals, and can be injected subcutaneously in the abdomen, in the thigh or in the upper arm.
5 Post-Market Adverse Reactions). The injection site and timing can be changed if needed without dose adjustment. 5 Missed Dose If a dose of VICTOZA® is missed take your dose on the next day as usual. Do not take an extra dose or increase the dose on the following day to make up for the missed dose.
5 Overdose From clinical trials and marketed use overdoses have been reported up to 40 times the recommended maintenance dose (72 mg). One case of a 10-fold overdose (18 mg daily) given for 7 months has been reported. All patients recovered without complications.
The patients reported severe nausea, vomiting and diarrhea. Severe hypoglycemia has been observed. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.
The patient should be observed for clinical signs of dehydration and blood glucose should be monitored. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
6 Dosage Forms, Strengths, Composition and Packaging Table – Dosage Forms, Strengths, Composition and Packaging VICTOZA® comes in a pre-filled disposable pen, comprising of a pen injector assembled with a cartridge (3 mL). The cartridge is made of glass (type 1), containing a bromobutyl rubber closure shaped as a plunger and closed with a bromobutyl/polyisoprene rubber closure.
The pen injector is made of polyolefin and polyacetal. When incinerated these materials only result in non-toxic waste products (carbon dioxide and water). Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients subcutaneous Injectable, 6 mg/mL Disodium phosphate dihydrate, propylene glycol, phenol and water for injections.
8 mg. VICTOZA® is a clear, colorless solution. Each 1 mL of […]